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CMS Finalizes Rule Rebranding ‘Meaningful Use’ Program to ‘Promoting Interoperability’

Ongoing federal regulatory push for EHR interoperability requires medical laboratories and anatomic pathology groups to have strategies for ensuring seamless interfaces with providers and hospitals

What difference does a name make? Clinical laboratories and anatomic pathology groups soon may know the answer to that question following the renaming of the Centers for Medicare and Medicaid Services (CMS) “Meaningful Use” program to “Promoting Interoperability” (PI).

CMS first announced the rebranding in April as part of a proposed rule aimed at transforming the Meaningful Use aspect of the federal Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH has been Medicare’s roadmap to electronic health record (EHR) implementation and interoperability since it was enacted in 2009.

The final rule arrived on August 2, 2018, and it may impact how clinical laboratories interface with provider and hospital EHRs.

Removing Obstacles to Quality Patient Care

In the news release outlining the updates to Medicare payment policies and rates under the Inpatient Prospective Payment System and the Long-Term Care Hospital Prospective Payment System, CMS states the “overhaul” of the meaningful use program will:

  • Make the program more flexible and less burdensome;
  • Emphasize measures that require the exchange of health information between providers and patients; and,
  • Incentivize providers to make it easier for patients to obtain their medical records electronically.

“We’re excited to make these changes to ensure care will focus on the patient, not on needless paperwork,” CMS Administrator Seema Verma stated in the news release. “We’ve listened to patients and their doctors who urged us to remove the obstacles getting in the way of quality care and positive health outcomes. Today’s final rule reflects public feedback on CMS proposals issued in April and the agency’s patient-driven priorities of improving the quality and safety of care, advancing health information exchange and usability, and removing outdated or redundant regulation on healthcare providers to make way for innovation and greater value.” (Photo copyright: Centers for Medicare and Medicaid Services.)

According to a CMS fact sheet, key provisions of the overhaul include:

  • The rule finalized an EHR reporting period to a minimum of any continuous 90-day period in each of calendar years 2019 and 2020 for new and returning participants attesting to CMS or their State Medicaid agency;
  • For the Medicare Promoting Interoperability Program, the rule finalized a new performance-based scoring methodology consisting of a smaller set of objectives that CMS states will provide a more flexible, less-burdensome structure, allowing eligible hospitals and critical access hospitals (CAHs) to place their focus back on patients;
  • CMS finalized two new e-Prescribing measures related to e-prescribing of opioids (Schedule II controlled substances); and,
  • Beginning with an EHR reporting period in CY 2019, all eligible hospitals and CAHs under the Medicare and Medicaid PI programs will be required to use the 2015 Edition of Certified EHR Technology;
  • CMS finalized changes to measures, including removing certain measures CMS believes do not emphasize interoperability and the electronic exchange of health information.

According to CMS, about 3,300 acute care hospitals and 420 long-term care hospitals will be subject to the final rule, which takes effect October 1. Obviously, medical laboratories servicing these healthcare organizations will be similarly affected.

Rebranding More than a Name Change

Healthcare Informatics analyzed the 2,593-page final rule explaining that the “core emphasis” of the meaningful use overhaul is “on advancing health data exchange among providers.”

The initial proposal in April, according to Healthcare Informatics, invited stakeholder feedback through a request for information on the possibility of revising CMS’ “Conditions of Participation” for hospitals by requiring providers to electronically transfer medically necessary information following a patient discharge or transfer. The final rule, however, did not include that change.

Instead, the CMS Fact Sheet on the rule states the April request for information was “to obtain feedback on positive solutions to better achieve interoperability, or the sharing of healthcare data between providers, which will inform next steps in advancing this critical initiative.”

Rebranding meaningful use is CMS’s first step in implementing core pieces of the Administration’s MyHealthEData Initiative to strengthen interoperability. In remarks during the ONC Interoperability Forum in Washington, DC, CMS Administrator Seema Verma described the rebranding decision as “much more than a name change” and signaled future CMS actions.

“It is a change in direction for the programs—from programs that support the adoption of health IT, to programs that promote interoperability and patient access to data,” she explained. “To avoid payment reductions and gain incentives, doctors and hospitals will have to give patients electronic access to their health records. We are also considering whether CMS should require—as a condition of participation in the Medicare program—that providers share data with patients in a universal electronic format and hope to share more information on that soon.”

The recent changes follow passage of the Bipartisan Budget Act of 2018, which included a provision relaxing meaningful-use requirements. Though the legislation affects only hospitals and outpatient Medicaid providers, Robert Tennant, Director of Health Information Technology Policy for the Medical Group Management Association (MGMA), declared the revision a “huge win” for providers.

“I don’t think the government recognized how difficult it would be to move from stage 1 to stage 2 to stage 3 [meaningful use] requirements and the significant costs involved,” Tennant stated told Modern Healthcare. “We hope that it signals an interest in Congress in having the administration and HHS (Federal Health and Human Services) not make these quality reporting programs so onerous that it results in large swaths of providers not being successful.”

Clinical laboratories and anatomic pathology groups should be aware that interoperability between their laboratory information systems and the EHRs of providers and hospitals continues to be important. Although the term “Meaningful Use” is to be supplanted by “Promoting Interoperability,” the ability to move patient health information seamlessly among providers continues to be a major goal of this country’s healthcare system.

—Andrea Downing Peck

Related Information:

CMS Finalizes Changes to Empower Patients and Reduce Administrative Burden

In Proposed MU Rebranding Rule, CMS Raises the Interoperability Stakes

Fact Sheet: Fiscal Year (FY) 2019 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Acute Care Hospital (LTCH) Prospective Payment System Final Rule (CMS-1694-F)

H.R. 1892: Bipartisan Budget Act of 2018

Printable PDF: Final Rule (CMS-1694-F)

Speech: Remarks by Administrator Seema Verma at the ONC Interoperability Forum in Washington, DC

Congress Budget Deal Relaxes Meaningful-Use Requirements

CMS Proposes Changes to Empower Patients and Reduce Administrative Burden

CMS Proposes Meaningful Use Changes to Promote Interoperability

 

 

Patients Who Post Negative Comments about Healthcare Experiences on Social Media Review Sites Are Being Sued by Physicians and Hospitals; Clinical Laboratories Might Be Similarly Vulnerable to Being Drawn into Lawsuits

Defamation, libel, harassment, and causing emotional distress are some of the charges patients who launched online negative review campaigns are defending themselves against in court

Healthcare systems, surgeons, family practitioners, clinical laboratories, anatomic pathologists—none are immune to receiving negative online reviews from patients who believe they’ve been damaged by their caregivers. And these reviews can have such an impact on practice revenues, doctors and hospitals have begun suing patients for damages caused by harmful online reviews. And they are winning.

Several notable cases involve high-profile healthcare systems. One such lawsuit involved the Cleveland Clinic. A patient who claimed a 2008 prostate surgery left him impotent and incontinent due to negligence on the part of the surgeon launched a negative campaign that spanned a decade, USA Today reported.

David Antoon, a retired Air Force Colonel, filed a malpractice lawsuit against urologist, Jihad Kaouk, MD, and the Cleveland Clinic. Antoon alleged Kaouk was not present in the operating room during his surgery, even though he insisted that only Kaouk perform the procedure. Antoon also claimed the Cleveland Clinic’s urology department did not have the proper credentials to operate the robotic device used during his surgery.

In addition to filing the lawsuit, Antoon complained to the federal Centers for Medicare and Medicaid Services (CMS) and the State Medical Board of Ohio.

However, Antoon also vented his frustrations on social media, as well as sending e-mails to Kaouk, which the doctor felt were threatening and made him concerned about the situation escalating. “What would be next—showing up at my door?” Kaouk asked during the criminal trial against Antoon. “That’s what we feared.”

Jihad Kaouk, MD (above), a urologist with the Cleveland Clinic, giving testimony at Cuyahoga County Common Pleas Court during a lawsuit involving patient David Antoon, a retired Air Force Colonel. Kaouk and the Cleveland Clinic prevailed in that lawsuit and the State Medical Board of Ohio closed a five-year investigation into Kaouk without reprimanding him. (Photo copyright: USA Today.)

Antoon posted unfavorable online comments about Kaouk for a decade. The urologist eventually petitioned the court, which granted him a civil stalking protective order against Antoon. It banned Antoon from contacting the doctor. Nevertheless, the day after that order was granted, Antoon posted another bad review about Kaouk on Yelp and urged people to avoid Kaouk when seeking medical care.

Antoon was later arrested on felony charges of menacing by stalking, telecommunications harassment, and violating a protection order. He faced up to one year in prison if indicted. In addition to spending two days in jail, he paid $40,000 for a defense attorney and a $50,000 bond after being arrested. He also agreed to pay $100 as part of a plea deal.

Above is David Antoon (left), Col USAF Ret, and Don Malarcik (right), an attorney with Malarcik, Pierce, Munyer, and Will in Akron, Ohio. Malarcik argued that “the Yelp review doesn’t violate the protection order because Antoon did not make direct contact with Kaouk,” Cleveland.com reported. (Photo copyright: USA Today.)

Other Lawsuits Against Patients Involving Social Media

Joon Song, MD, PhD, a New York City area gynecologist sued patient Michelle Levine over critical reviews she left about his practice on several online sites. Though Levine removed her posts from the sites after being sued, Song wants her to pay $1 million in legal fees and damages. The doctor accused Levine of defamation, libel, and causing emotional distress. Sound familiar?

Two Scottsdale, Ariz., doctors—Albert Carlotti, MD, and Michelle Cabret-Carlotti, MD, DDS,—successfully sued patient Sherry Petta for defamation after she posted negative statements about the doctors online. After filing a complaint with the Arizona Medical Board and clashing with Carlotti over access to her medical records, Petta posted unfavorable reviews about the practice on several online sites and created a website to warn others about Carlotti. The doctors claimed the statements Petta made were untrue and portrayed them in a false light. A jury agreed and awarded the doctors $12 million, which was later vacated on appeal.

Cleveland cosmetic surgeon Bahman Guyuron, MD, sued a former patient after she posted adversarial reviews on several online review sites about her dissatisfaction with a nose job. The patient, who remains unidentified, alleges that Guyuron acted in an untrustworthy and unprofessional manner, that she received no follow-up care, and that Guyuron urges people to post erroneous positive reviews online. She also claims that there was no informed consent to the procedure and that her nose is now twice as large as before.

Guyuron is seeking monetary damages, an injunction against the patient to prevent her from posting negative reviews about him online, and an order to remove all existing statements about him from the Internet.

Clinical Laboratories Vulnerable to Negative Reviews

Healthcare is complicated and positive outcomes can never be guaranteed. When patients do not get satisfaction by complaining to the doctors and facilities, they may seek other ways to be heard. And negative comments made on social media and online review websites can harm the reputations and businesses of physicians and medical facilities.

“It would be great if the regulators of hospitals and doctors were more diligent about responding to harm to patients, but they’re not, so people have turned to other people,” Lisa McGiffert, former head of the Consumer Reports Safe Patient Project, told USA Today. “This is what happens when your system of oversight is failing patients.”

However, Ryan Lorenz, Petta’s attorney warns consumers to be aware of the consequences of posting critical online reviews, especially if they post factually inaccurate information. “Make sure what you are saying is true—it has to be truthful,” he told USA Today.

Similar situations can arise in the clinical laboratory industry as well. There were multiple postings on Yelp in 2014 and 2015 by patients criticizing blood-testing company Theranos regarding discordant test results they’d received from Theranos’ lab, which Dark Daily covered in multiple e-briefings.

Trust is the hardest thing to earn, the easiest thing to lose, and once gone, can be impossible to get back. Clinical laboratories are just as susceptible to negative reviews as hospitals and doctors.

Worse yet, labs can be drawn into lawsuits simply because they service the hospital systems and caregivers involved. Preparing in advance for this possibility should be on every clinical laboratory manager’s do list.

—JP Schlingman

Related Information:

Doctors, Hospitals Sue Patients Who Post Negative Comments, Reviews on Social Media

Doctor Sues Patient for $1 Million for Posting Negative Reviews Online

I Wrote a Negative Yelp Review—and it Made My Life a Nightmare

Hospital Sues Over Facebook Post and Picketing

Previously High-Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost

Federal Appeals Court Rules Yelp Not Responsible for Bad Reviews; Labs Advised to Examine Their Online Presence

Online Negative Reviews Can Threaten Clinical Laboratories Not Prepared to Address Feedback or Manage Their Internet Presence

Leapfrog Group Report Shows Hospitals Failing to Eliminate Hospital-Acquired Infections; Medical Laboratories Can Help Providers’ Antimicrobial Stewardship Programs

Contrary to CMS and Joint Commission programs implemented in 2017 to reduce them, incidents of hospital-acquired infections have risen for the past few years

Clinical laboratories and anatomic pathologists know that hospital-acquired infections (HAIs) can be deadly, not just for patients, but for their caregivers and families as well. Even one HAI is too many. Thus, the federal Centers for Medicare and Medicaid Services (CMS) required healthcare organizations to upgrade their antimicrobial stewardship (AMS) programs to meet CMS requirements and Joint Commission accreditation starting in 2017.

Nevertheless, a recent Leapfrog Group report indicates hospitals are finding it increasingly difficult to remove infections all together. This has many healthcare leaders concerned.

The report, which was analyzed by Castlight Health, states that the number of hospitals reporting zero infections has declined significantly since 2015, according to a news release. According to the Leapfrog Group’s report:

  • Two million people acquire HAIs every year;
  • 90,000 people die annually from HAIs;
  • HAI costs range from $1,000 to $50,000 depending on the infection.

Hospitals spend $28 to $45 billion annually on HAI costs, Healthcare Finance reported.

“I think it’s far too easy to let something slip, so it’s clear that there really needs to be a renewed focus on getting back to zero. We do still see some hospitals that are getting to zero, so it’s clearly possible,” Erica Mobley (above), Leapfrog Group’s Director of Operations, told Fierce Healthcare. (Photo copyright: LinkedIn.)

Regressing Instead of Progressing Toward Total HAI Elimination

Leapfrog Group’s report is based on 2017 hospital survey data submitted by 2,000 providers. The data indicates that in just two years the number of hospitals reporting zero HAIs dropped by up to 50%. The reported HAIs include:

The remaining infection measures studied by Leapfrog Group had less dramatic decreases over the same time period, according to Fierce Healthcare. Nevertheless, they are significant. They include:

  • Surgical site infections (SSI) following colon surgery: 19% zero infections compared to 23% previously;
  • Clostridium difficile (C. difficile) inpatient infections: 3% zero inpatient infections in 2017, compared to 5% in 2015.

Joint Commission Studies Antimicrobial Program Progress

Meanwhile, the Joint Commission acknowledged that implementation of antimicrobial stewardship programs by providers can be difficult. In “The Expanding Role of Antimicrobial Stewardship Programs in Hospitals in the United States: Lessons Learned from a Multisite Qualitative Study,” the accrediting organization released insights from interviews with 12 antimicrobial stewardship program leaders nationwide.

They published their study in “The Joint Commission Journal on Quality and Patient Safety.” Three themes emerged from the interviews:

  • Hospitals have revised their antimicrobial programs, which originally operated on a “top-down” structure, to programs that include clinicians from throughout entire provider organizations;
  • Health information technology (HIT) can enable real-time opportunities to launch antimicrobial therapy and treat patients; and,
  • Some barriers exist in getting resources to integrate technology and analyze data.

“These programs used expansion of personnel to amplify the antimicrobial stewardship programs’ impact and integrated IT resources into daily workflow to improve efficiency,” the researchers wrote. “Hospital antimicrobial stewardship programs can reduce inappropriate antimicrobial use, length of stay, C. difficile infection, rates of resistant infections, and cost.”

What Do CMS and Joint Commission Expect?

According to Contagion, while the Joint Commission program is part of medication management, CMS places its requirements for the antimicrobial stewardship program under “infection prevention.”

CMS requirements for an antimicrobial stewardship program include:

  • Developing antimicrobial stewardship program policies and procedures;
  • Implementing hospital-wide efforts;
  • Involving antimicrobial stakeholders for focus on antimicrobial use and bacterial resistance;
  • Setting evidence-based antimicrobial use goals; and,
  • Reducing effects of antimicrobial use in areas of C. difficile infections and antibiotic resistance.

Leapfrog Group’s data about fewer hospitals reporting zero infections offers opportunities for hospital laboratory microbiology professionals to get involved with hospital-wide antimicrobial program teams and processes and help their hospitals progress back to zero HAIs. Clinical laboratories, both hospital-based and independent, also have opportunities to contribute to improving the antimicrobial stewardship efforts of the physicians who refer them specimens.

—Donna Marie Pocius

Related Information:

Troubling New Report on Hospital Infections Comes While Centers Medicare and Medicaid Services Considers Discontinuing Publicly Reporting Rates

Leapfrog Group: Healthcare-Associated Infections

Antimicrobial Stewardship Standards: A Comparison of Centers for Medicare and Medicaid Services and Joint Commission Requirements

Joint Commission: New Antimicrobial Stewardship Standard

Core Elements of Hospital Antibiotic Stewardship Programs

Number of Hospitals Achieving Zero Infections Drops

Hospitals Losing Ground on Effectively Preventing Infections with Dramatic Drop in Those Reporting Zero Infections

The Expanding Role of Antimicrobial Stewardship Programs in Hospitals in the United States: Lessons Learned from a Multi-Site Qualitative Study

Administrative Costs Highest in US, According to NEJM and Health Affairs Studies; Reduction Efforts Will Impact Clinical Laboratories

Clinical laboratory test claims make up a substantial proportion of all claims filed each year. Thus, any effort to streamline or reform claims adjudication and administration in the US will alter how labs and pathologists conduct business

Clinical laboratory managers and anatomic pathologists know how costly and complex the US healthcare system can be. However, expenses associated with care and treatment are only part of the total picture. Resources devoted to paperwork and administrative costs apparently increase overall expenditures associated with healthcare to a much higher degree than is generally known.

That’s according to several studies The New York Times reported on in July.

US Administrative Costs Higher than All Other Nations

One study conducted by The New England Journal of Medicine (NEJM) in 2003 estimated administrative costs account for approximately 30% of all healthcare expenditures in the US. The researchers examined data from 1999 to reach those conclusions. In today’s economy, those numbers are higher. On average, $5,700 of every $19,000 that US workers and their employers pay for family coverage each year goes towards administrative costs.

A 2014 study published by Health Affairs compared administrative costs for US hospital expenditures to those of seven other countries: Canada, England, France, Germany, the Netherlands, Scotland, and Wales. This study evaluated data from 2010/2011 and found that hospital administrative costs in the US far exceed rates in other nations. According to the study, administrative costs accounted for:

  • 25.3% of total hospital expenditures in the US;
  • 19.8% in the Netherlands;
  • 15.5% in England; and,
  • 12% in Canada and Scotland.

According to the Health Affairs study, more than $150 billion could have been saved in 2011 by reducing per capita spending for administrative costs to the levels observed in Canada and Scotland.

“The extraordinary costs we see are not because of administrative slack or because healthcare leaders don’t try to economize,” Kevin Schulman, MD, Professor, Department of Medicine, Duke University, and co-author of the Health Affairs study told The New York Times. “The high administrative costs are functions of the system’s complexity.” (Photo copyright: Duke University.)

Complexity of Payer System Partly to Blame

One reason for the costliness in the US healthcare system is the myriad of payers that healthcare organizations have to grapple with to receive payment. Private health insurers and public health programs like Medicare and Medicaid, each have their own procedures, regulations, and forms that need to be submitted to receive payments. This translates to more employee time devoted to billing.

Another factor driving costs is the staff time devoted to the collection of debts. A 2017 Health Affairs study examined medical claims data from 88,000 healthcare providers contracted with Athenahealth to determine the percentage of bills paid within one year from the initial service.

The study found that 93.8% of patient bills under $35 were paid within a year. However, that percentage decreased as the patient obligation increased:

  • 90.5% of patients paid bills between $35 and $75 within one year;
  • 83.7% paid bills between $75 and $200 in the same time period; however,
  • When bills increase to $200 or more, just 66.7% were paid within a year’s time.

Providers wrote off approximately 16% as abandoned or bad debts, with an additional 17% going to collection agencies.

Another study, published in Health Affairs in 2009, surveyed 895 physicians about the time they spent dealing with administrative tasks. On average, physicians reported spending 43 minutes per workday interacting with health plans. This number is the equivalent of three hours/week and almost three weeks/year. Those numbers have reportedly increased since then.

EHRs Do Not Reduce Administrative Costs, Contrary to Belief

Efforts have been made to reduce administrative costs in the US healthcare industry. One such measure involved increased use of certified electronic health record (EHR) systems, which the federal government spent billions of dollars promoting and incentivizing providers to adopt on the claim that EHRs would reduce healthcare costs, in part by removing most of the paperwork.

However, a 2018 study published in the Journal of the American Medical Association (JAMA) reported the adoption of EHRs did not reduce administration costs. Researchers at Duke University and Harvard Business School utilized a cutting-edge accounting method to determine the administrative costs within a large academic healthcare system that was using a certified EHR.

Their study determined the administrative costs for processing a single medical bill ranged from $20 for a doctor visit to $215 for an inpatient surgical procedure. These costs accounted for 3%-25% of total professional revenue for the provided services.

“We need to understand better how complexity is driving these enormous costs within the system, costs that do not add value to patients, employers, or providers,” noted Barak Richman, JD, PhD, Duke University School of Law and Margolis Center for Health Policy, one of the study’s authors.

Clinical Lab Test Claims a Major Portion of Administrative Costs

Nevertheless, administrative costs are a necessary part of doing business and not always as negative as perceived. An article published by Health Affairs in 1992 divided administrative costs in the healthcare industry into four categories:

  • Transaction-related: claims processing, billing, admissions, and tracking employee hiring/terminations;
  • Benefits Management: quality assurance, plan design, statistical and internal analyses, and management information systems;
  • Selling and Marketing: strategic planning, underwriting, and advertising; and,
  • Regulatory and Compliance: waste management, licensing requirements, and discharge planning.

“We hope that this work is the first step toward informing policy solutions that could reduce these non-value-added costs largely hidden within the healthcare system,” Schulman stated in a Duke University news release.

The issue of costly paperwork and administrative expenditures is significant for the clinical laboratory profession as lab test claims make up a substantial portion of all medical claims filed annually. Efforts to streamline or reform claims adjudication and administration will have an impact on the way clinical labs and anatomic pathology groups conduct business in the future.

—JP Schlingman

Related Information:

Hidden from View: The Astonishingly High Administrative Costs of U.S. Health Care

NEJM: Costs of Health Care Administration in the United States and Canada

Heath Affairs: A Comparison of Hospital Administrative Costs in Eight Nations: US Costs Exceed All Others by Far

Heath Affairs: Inside the Black Box of Administrative Costs

Heath Affairs: As Patients Take on More Costs, Will Providers Shoulder the Burden?

Heath Affairs: What Does It Cost Physician Practices to Interact with Health Insurance Plans?

Electronic Health Records Don’t Reduce Administrative Costs

Simplifying Administration of Health Insurance

Are Patients Becoming the New Payers? Analysis by TransUnion Suggests This Might Be the Case and the Implications for Clinical Laboratories Could Be Profound

Healthcare revenue cycle consultant Jonathan Wiik suggests healthcare providers must prepare their organizations for patients who need help paying increasing medical costs

When patients cannot pay their bills, all of healthcare—including clinical laboratories and anatomic pathology groups—also struggle. And, according to experts, medical laboratories already complying with federal value-based payment programs and precision medicine directives should expect increased pressure from patients seeking ways to pay for their services.

A recent analysis of this issue by TransUnion Healthcare (NYSE:TRU) states, “patients experienced an 11% increase in average out-of-pocket costs during 2017, rising from $1,630 in Q4 2016 to $1,813 in Q4 2017.” It is a development that should send up red flags to clinical laboratory managers seeking ways to maintain and increase revenues.

“Given the increased payment responsibility, being able to determine a patient’s ability to pay is increasingly important for hospitals,” noted Jonathan Wiik, Principal, Healthcare Strategy at TransUnion Healthcare (TRU). “In order to allow patients to focus on getting the care they need healthcare providers need processes and tools in place to help patients meet their financial obligations and to establish funding mechanisms that will benefit both the patient and provider.” Obviously, this also applies to clinical laboratories.

According to a news release, “The [TRU] analysis also revealed that in 2017, on average, 49% of patient out-of-pocket costs per healthcare visit were below $500; 39% were $501-$1,000; and 12% were more than $1,000.”

For providers, patients’ swelling unpaid balances mean more uncompensated care, the analysis also showed. And that means more unpaid balances for clinical laboratories as well.

“Increasing healthcare costs and patient responsibility is a continuing trend that does not seem to be slowing anytime in the near future,” noted Jonathan Wiik (above) Principal, Healthcare Strategy, at TransUnion Healthcare and author of the new book “Healthcare Revolution: The Patient Is the New Payer,” during a HIMSS 2018 presentation. (Photo copyright: Colorado Managed Care Collaborative.)

Patients Struggle to Pay Amounts Under $500

Each year, more healthcare consumers are forced onto high-deductible health plans (HDHPs) that make them responsible for thousands and even tens of thousands of dollars in upfront costs.

And according to another TRU news release, patients with commercial insurance plans experienced a 67% increase in their financial responsibility over five years. In other words, after insurance plans paid providers, patients still needed to pony up 12.2% of the total bill in 2017, as compared to 8% in 2012.

During the most recent year studied by TransUnion Healthcare, patients’ out-of-pocket costs increased 11%, rising to $1,813 in 2017 from $1,630 in 2016, a news release revealed.

And it doesn’t take a huge bill for patients to feel the pain. TransUnion’s data reveals that 68% of patients with medical bills below $500 did not fully pay what they owed, RevCycle Intelligence reported. This has major implications for clinical laboratories and anatomic pathology groups because many lab charges fall under $500 and TransUnion shows that almost 70% of patients do not pay the full amount of these bills.

According to TRU, medical specialties with the highest out-of-pocket estimated amounts due from patients include:

  • Orthopedics, $1,663;
  • Plastic surgery, $1,566;
  • Urology, $1,415; and,
  • Neurology, $1,241.

The average deductible was $1,200 in 2016, up from just $303 in 2006, a 176% increase, Healthcare Dive reported, citing a new Peterson-Kaiser Health System Tracker report.

And, as Dark Daily previously reported, affluent and self-employed people also feel the pinch, as deductibles can be as high as $5,000/year for individuals and more than $10,000/year for a families, whether plans are purchased through the Affordable Care Act (ACA) or employers.

What Happens When Patients Don’t Pay?

Dark Daily also reported on a 2017 TransUnion Healthcare analysis that showed 99% of hospital bills of $3,000 or more were not paid in full by the end of 2016. (See, “Hospitals, Pathology Groups, Clinical Labs Struggling to Collect Payments from Patients with High-Deductible Health Plans,” September 6, 2017.)

When patients cannot afford to pay their bills, hospitals’ bad debt and charity-care levels rise. Together, bad debt and charity care comprise a provider’s uncompensated care.

“A lot of patients can’t afford these bills, which is why uncompensated care has bounced,” Wiik told Modern Healthcare.

Indeed, uncompensated care was $38.3 billion in 2016, up $2.6 billion since 2015, according to an American Hospital Association (AHA) 2017 fact sheet.

Meanwhile, the Centers for Medicare and Medicaid Services (CMS) reported that Medicare bad debt (the effect of Medicare patients not paying deductibles and co-pays) increased to $3.69 billion in 2016 from $3.14 billion in 2012, a 17% bump, TransUnion Healthcare pointed out.

Consumers Say They Want Prices, Financing Plans

Consumers say healthcare providers are not transparent about costs for procedures, nor do they effectively offer financing options. That’s according to a HealthFirst Financial news release, which states, “More than three-quarters, or 77%, of healthcare consumers say it’s important or very important they know their costs before treatment and 53% want to discuss financing options before care. However, the vast majority of healthcare providers are not satisfying these consumer demands.”

And, according to a HealthFirst Financial Patient Survey of 1,011 adults nationwide:

  • “53% voice concern about the ability to pay a medical bill of less than $1,000;
  • “35% worried about the ability to pay a bill of less than $500; and,
  • “16% are concerned about the ability to pay a bill of less than $250.”

These numbers fall well into the amounts clinical laboratories charge for services rendered.

What Can Medical Laboratories Do?

To help their customers pay their bills and improve revenue, Dark Daily suggest labs:

  • Use software that enables ordering clinicians to process advanced beneficiary notices and prior authorizations for services;
  • Inform the customer prior to specimen collection about their financial responsibility for the test;
  • Ask for payment-due at time of the patient encounter;
  • Share key lab test price data in easily accessible and understandable ways;
  • Keep credit card information securely on-hand for agreed-to balances patients are responsible for paying; and,
  • Offer payment options, such as e-billing and financing plans.

As we’ve pointed out many times, because clinical laboratories are dependent on the physicians and hospitals they service, they are particularly vulnerable when patients stop paying their bills.

—Donna Marie Pocius

Related Information:

TransUnion Healthcare Analysis: Fight Rising Uncompensated Care

Patient Balances Continue to Increase in 2018, Driving Bad Debt and Uncompensated Care

Patient Payment Responsibility Increases 11% in 2017

Patient Financial Responsibility Increased 11% in 2017

It’s Never Too Soon to Communicate Pricing and Payment Options

Deductibles, Coinsurance on the Rise, But Cost of Copays Are Down

Growing Bad Debt Problem Illustrates Broken Billing System

American Hospital Association Uncompensated Care Cost Fact Sheet, December 2017 Update

From Millennials to Boomers, Patients Want to Discuss Healthcare Pricing and Payment Options Before Treatment

Even Higher Income Americans Are Frustrated with High Health Insurance Costs and Many Drop Coverage and Switch to Concierge Care

Hospitals’ Pathology Groups and Clinical Labs Struggling to Collect Payments from Patients with High Deductible Health Plans

Previously High-Flying Theranos Provides Clinical Laboratories and Pathology Groups with Valuable Lesson on How Quickly Consumer Trust Can Be Lost

Affected patients speak about emotional, financial, and medical costs of receiving inaccurate results from the startup’s faulty Edison ‘finger-stick’ blood draw testing device

Healthcare consumers trust America’s clinical laboratories and anatomic pathology groups to provide accurate test results. When those test results are inaccurate, the loss of public trust can trigger a sharp decline in referrals/revenue and draw an avalanche of lawsuits by those harmed by inaccurate results.

The most recent example of this object lesson is disgraced blood testing company Theranos, previously estimated to be worth $9 billion but now struggling to stay afloat. The once high-flying startup has been brought to the edge of bankruptcy in the aftermath of a fraud settlement with the Securities and Exchange Commission (SEC), sanctions from the Centers for Medicare and Medicaid Services (CMS), investor lawsuits, consumer lawsuits, and a settlement with Walgreens over claims about Theranos’ Edison portable blood analyzer.

Theranos first made its unproven finger-stick blood draw device available to consumers in September 2013, when it announced a partnership with drugstore chain Walgreens (NASDAQ:WBA). At its height, Theranos operated 40 “Wellness Centers” in Walgreens stores in Arizona and a single location in California, which were the source of much of its revenue. USA Today reported the metro Phoenix-area centers alone sold more than 1.5 million blood tests, which yielded 7.8 million tests results for nearly 176,000 consumers. Theranos shuttered the wellness centers in 2016 after CMS inspectors found safety issues at Theranos’ laboratories in California and a Wall Street Journal (WSJ) investigation raised questions about the company’s testing procedures and accuracy claims. Ultimately, Theranos voided the results of all blood tests run on its Edison device from 2014 through 2015.

Breast-cancer survivor Sheri Ackert (above) told the WSJ she panicked when blood-test results from Theranos indicated her cancer may have reoccurred or were indicative of a rare type of tumor. After being retested by a different clinical laboratory, her results were found to be normal. Click here to watch a WSJ video about Ackert’s experience. (Photo/video copyright: Mark Peterman/Adya Beasley/Wall Street Journal.)

USA Today outlined the impact Theranos’ supposedly low-cost, cutting-edge technology had on several customers:

  • A woman inaccurately diagnosed with the thyroid condition Hashimoto’s disease changed her lifestyle, made unnecessary medical appointments, and took medication she didn’t need;
  • A woman inaccurately diagnosed with the autoimmune disease Sjögren’s syndrome was checked for food allergies before being retested and found not to have an autoimmune condition; and,
  • An Arizona resident who had heart surgery visited a Theranos clinic five times to monitor the results of blood-thinning drug warfarin and was switched to a different drug. He had to have a second heart surgery to drain blood from the pericardial sac and believes more accurate test results could have averted the follow-up operation.

Arizona resident Steven Hammons visited a Theranos clinic several times to have his blood tested. He’d been placed on blood thinners following heart surgery. He was taken off the blood thinners presumably based on the results of those tests. However, as USA Today reported, one test result was later found to be inaccurate. Hammons, who underwent a second procedure to remove blood that had built up around his heart, told USA Today he was concerned about the safety of his fellow citizens.

“That makes me very concerned and worried for the safety of other Arizonans,” said Hammons, who once worked in the medical services division of a private health insurance company. “Government had a role in patient safety. The powers that be dropped the ball.”

Arizona Attorney General Mark Brnovich spearheaded a lawsuit against Theranos under the state’s Consumer Fraud Act, which led to a $4.65 million settlement covering full refunds for every Arizona customer who used the company’s testing services.

“Theranos may have not only had some erroneous test results, but they may have misread my rising blood pressure level as well,” Brnovich told The Republic in a 2017 article announcing the state’s fraud settlement with Theranos. “They said that about 10% of the results were inaccurate. The problem is, as an Arizona consumer, you don’t know whether you were part of that class or not.”

Downfall of a Once-Vaunted Clinical Laboratory Company

Dark Daily and sister publication The Dark Report have written extensively about these events. Former CEO Elizabeth Holmes founded Theranos in 2003 when she was just 19-years old. By 2013, Holmes had become a media sensation based on her claims that “Theranos had developed a medical technology that could do what seemed to be impossible: Its secret machines could run thousands of medical tests using the blood from a tiny finger-prick, and do so quickly and cheaply,” Bloomberg reported in a recent article outlining Holmes’ fall from grace.

While Holmes continues in the role of Chairman of Theranos’ Board of Directors, she was stripped of control of the company as part of the SEC settlement in 2016. The SEC found Holmes and then-company President Ramesh “Sunny” Balwani had fabricated claims Theranos technology had been validated by the Food and Drug Administration (FDA) and pharmaceutical companies and battle-tested by the US military in Afghanistan.

As a result, the SEC also barred Holmes from serving as an officer or director of any public company for 10 years. In October 2016, Theranos announced it would be closing its laboratory operations and focusing on its effort to create miniature medical testing machines, which it did. Nevertheless, the fallout continues.

As pressures on medical laboratories and pathology groups to cut costs while delivering quality care and value increases, laboratory leaders must not lose sight of the fact that accuracy of results remains the key to maintaining trust with healthcare consumers and a financially viable business.

—Andrea Downing Peck

Related Information:

Theranos, CEO Holmes, and Former President Balwani Charged with Massive Fraud

Theranos Receives Notice of Sanctions from the Centers for Medicare & Medicaid Services

Two More Investors Sue Theranos and Elizabeth Holmes for Fraud

Theranos Hit with Consumer Lawsuit over Faulty Blood Tests

Theranos, Walgreens Reportedly Reach a Deal to Settle Suit for under $30 Million

Theranos Selects Walgreens as a Long-Term Partner Through Which to Offer Its New Clinical Laboratory Service

An Open Letter from Elizabeth Holmes

How Startup Theranos Has Struggled with its Blood-Test Technology

Theranos Reaches $4.65 Million Fraud Settlement with Arizona

As Theranos Drama Unwinds, Former Patients Claim Inaccurate Tests Changed Their Lives

Theranos Statement on CMS 2567 Report

Agony, Alarm and Anger for People Hurt by Theranos’ Botched Blood Tests

Blood, Fraud and Money Led to Theranos CEO’s Fall from Grace

Holmes, Balwani Indicted by Department of Justice

Theranos News Gets Worse for the Former Silicon Valley Hero

After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Now Theranos Faces Criminal Investigation on Whether the Clinical Laboratory Company Misled Investors, according to Published Reports

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